Healthy Skepticism Library item: 18857

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Publication type: Journal Article

Lenzer J, Brownlee S
Why the FDA can’t protect the public
BMJ 2010 Nov 2; 341:
http://www.bmj.com/content/341/bmj.c4753.extract

Abstract:

In 1997, the US Food and Drug Administration’s neurological devices panel met to consider approval of a vagus nerve stimulator (VNS). The manufacturer, Cyberonics, said it could prevent or reduce seizures in patients with partial onset epilepsy who did not respond to drug treatment. The device consists of a generator the size of a matchbox that is implanted under the skin below the patient’s clavicle. Lead wires from the generator are tunnelled up to the patient’s neck and wrapped around the left vagus nerve at the carotid sheath, where it delivers electrical impulses to the nerve lasting about 30 seconds every 3-5 minutes.